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IRCT20170809035599N2 IRCT 2021-09-04 Ahvaz University of Medical Sciences Anti-diabetic Herbal Drug Preparation and comparison of anti-diabetic effects of palm kernel powder plates with placebo in diabetic patients treated with metformin 2021-09-23 anticipated 140 Complete https://irct.ir/trial/33611 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are placed in two intervention or control groups using allocation Random Software (RAS) through a four- and six-block block with a 1: 1 allocation ratio. Consume one every 12 hours for 90 days.Random allocation sequences will be generated by the non-researcher, cans will be numbered from 1 to 140. Both groups will receive routine metformin treatment, Blinding description: The patient receives the drug (date kernel plate or placebo) in sealed envelopes. The coding is done by one of the project partners and the doctor, the evaluator and the patient are blind. 3 Diabetes type2. Intervention 1: Intervention group: 70 patients in adition to metformin 500 mg tablets (one every 12 hours), palm kernel plate, are given one 200 mg capsule every 12 hours for 90 days. Intervention 2: control group: 70 patients in adition to metformin 500 mg tablets (one every 12 hours), placebo are given one capsule 200 mg every 12 hours for 90 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there inst more information.
public Zahra Farhangian
Golestan
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 5940 zarei-a@ajums.ac.ir Ahvaz University of Medical Sciences scientific Neda Mohtasham
Golestan
Ahvaz Iran (Islamic Republic of) 15794 - 61357 +98 61 3311 5940 mohtaham-n@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Having type 2 diabetes Less than 6 months have passed since the onset of the disease Fasting blood sugar is less than 200 and HbA1C is less than 9 Age 30-60 years 30 years 60 years Both Pregnant or lactating patient Age under 30 or over 60 years Advanced complications of diabetes Patients undergoing chemotherapy Z79.84 oral antidiabetic drugs Treatment - Drugs Placebo Intervention group: 70 patients in adition to metformin 500 mg tablets (one every 12 hours), palm kernel plate, are given one 200 mg capsule every 12 hours for 90 days control group: 70 patients in adition to metformin 500 mg tablets (one every 12 hours), placebo are given one capsule 200 mg every 12 hours for 90 days Fasting blood sugar, HbA1C ,2-hour blood sugar. Timepoint: Measurement of fasting blood sugar, HbA1C .Blood sugar 2 hours at the beginning of the study and after 3 months. Method of measurement: Blood glucose measuring device. Ahvaz University of Medical Sciences Approved 2021-06-26 Ahvaz Jundishapur University of Medical Science Golestan Ahvaz Khouzestan Iran (Islamic Republic of)